国产rhG-CSF防治化疗病人白细胞下降53例

53 Cases of Domestic rhG-CSF Preventing and Curing Leucopenia Caused by Chemotherapy

目的：观察国产重组人粒细胞集落刺激因子（ｒｈＧ－ＣＳＦ）对化疗病人血白细胞下降的防治作用及其不良反应。方法：将６９例癌症患者按３：１比例分别随机进入国产ｒｈＧ－ＣＳＦ组及进口ｒｈＧ－ＣＳＦ组，采取自身交叉对照的方法，在每例患者化疗的２个疗程中，一疗程加国产或进口ｒｈＧ－ＣＳＦ作为治疗疗程，而另一疗程不加 ｒｈＧ－ＣＳＦ作为对照疗程，比较每组各疗程及组间白细胞（ＷＢＣ）和中性粒细胞（ＡＮＣ）的变化，并观察不良反应。结果：国产ｒｈＧ－ＣＳＦ组治疗疗程ＷＢＣ和ＡＮＣ下降持续天数均明显低于其对照疗程，且 ＡＮＣ最低点亦高于对照疗程，因 ＡＮＣ下降而延迟下一疗程化疗的发生率明显低于对照疗程，与进口 ｒｈＧ－ＣＳＦ组的临床疗效基本一致。国产ｒｈＧ－ＣＳＦ组的不良反应多为发热、骨骼肌肉疼痛、皮疹、局部硬结，患者能耐受，与进口产品的不良反应无差异。结论：结合我国国情，从药物经济学角度考虑，国产ｒｈＧ－ＣＳＦ值得在临床上推广使用。

Objective: Observe preventing and curing effect and adverse reactions of domestic rhG - CSF against leu- copenia in patients with chemotherapy. Methods: 69 cancer patients were divided into two groups randomly according to 3: 1 proportion, one group treated by domestic rhG - CSF, the other group treated hy imported rhG - CSF. Self- cross control was adopted, among 2 courses of chemotherapy for each patient, one course add domestic or imported rhG - CSF as treated course, but another course does not add rhG - CSF as control course. Compare the change of leucocyte(WBC) and neutrophil (ANC) of every course in each group, also observe the adverse reactions. Results: For domestic rhG - CSF treated group, lasting period of WBC and ANC falling of treated course was obviously shorter than that of control course. And ANC minimum of treated course was higher than that of control course. Incidence of delay of the next course of chemotherapy cause hy ANC drops in treated course was also lower than that of con- trol course. Its clinical effect basically consistent with that of imported rhG - CSF groud. The adverse reactions in domestic rhG - CSF group were mainly fever, skeleton and muscle ache, rash, partly hardening, patients tolerate well, it have no difference with that of the imported products. Conclusion: Combining the national conditions of our country, from the point of pharmacoeconomics, domestic rhG - CSF is worth using widely in clinic.